Company

Pangea PharmaceuticalsSee more

addressAddressFort Lauderdale, FL
type Form of workFull-time
salary Salary$80,000 - $110,000 a year
CategoryInformation Technology

Job description

Manager - Regulatory Affairs

Responsibilities

  • The Regulatory Affairs Manager is responsible for ensuring the successful preparation, submission, and approval of ANDAs as well as post-approval submissions
  • This role will guide the regulatory processes for medical drug products, coordinating with internal teams and external agencies to achieve timely approvals
  • Lead the preparation, submission, and management of ANDAs
  • Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, and Clinical, to gather required documentation and data for submissions
  • Liaise with the FDA and other relevant regulatory bodies to ensure submissions are compliant and meet all required standards
  • Keep abreast of changes in regulatory guidelines, ensuring that all products under development align with these changes
  • Serve as the main contact for regulatory inspections and audits
  • Support the implementation of internal regulatory processes and standards
  • Help in the creation and maintenance of SOPs related to regulatory submissions

Qualifications

  • Demonstrated experience with successful ANDA or NDA approval for one or more drugs
  • Minimum 5 years experience with a pharmaceutical company in the Regulatory Affairs department
  • In-depth knowledge of FDA regulations and guidelines related to generic drugs
  • Strong communication, collaboration, and organizational skills
  • Ability to work efficiently in a dynamic, fast-paced environment
  • Proficiency in electronic document management systems and tools related to regulatory submissions (eCTD Proficient)
  • Project Management experience preferred
  • Bachelor’s degree in pharmacy, Biology, Chemistry, or a related field preferred

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

Benefits:

  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Experience level:

  • 5 years

Schedule:

  • Monday to Friday

Experience:

  • Pharmaceutical Companies: 5 years (Preferred)

Ability to Relocate:

  • Fort Lauderdale, FL 33304: Relocate before starting work (Required)

Work Location: In person

Benefits

Health insurance, Dental insurance, Paid time off, Vision insurance
Refer code: 8217009. Pangea Pharmaceuticals - The previous day - 2024-02-19 15:42

Pangea Pharmaceuticals

Fort Lauderdale, FL
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